Paradigm Biopharmaceuticals (ASX: PAR) has confirmed the potential of its injectable pentosan polysulfate sodium (iPPS) drug to be “safe and effective” in treating knee osteoarthritis pain after completing the Phase 2b clinical trial.
The Phase 2b clinical trial evaluated the effects iPPS had on knee pain on 112 patients and was completed in a little more than 12 months.
According to Paradigm, the trial generated “clinically meaningful and statistically significant results” when comparing iPPS to a placebo.
“To achieve clinically meaningful and statistically significant results between IPPS and placebo in the total population and highly clinically meaningful and highly statistically significant results in the NRS (numeric rating scale) = 4-6 strata is truly and outstandingly positive trial outcome,” Paradigm chief executive officer Paul Rennie said.
“If you have clinical significance and statistical significance, you have a high probability the drug will pass a phase 3 clinical trial and, once registered, a drug than can penetrate the market,” he added.
During the Phase 2b trial, 46.2% of those treated with iPPS reported a greater than 50% reduction in pain. This compares to 22.5% of patients who received a placebo.
Paradigm stated the Phase 2b trial results were consistent with the 183 patients who have been treated with iPPS via the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) where an average 51.4% in pain reduction was reported.
“The combined data from this trial support the high number of patients treated by their doctors via the TGA SAS and give us confidence that iPPS has to potential to be a safe, effective, long-lasting, non-opioid based treatment for knee osteoarthritis,” Paradigm chairman Graeme Kaufman said.
“Going forward, we will be releasing additional SAS data on knee osteoarthritis, but also other points, which will broaden the applicability of the potential of iPPS as an osteoarthritis pain reduction treatment,” he added.
As a result of the consistent positive results, Paradigm will file a new drug application with the US Food and Drug Administration and plans to begin the phase 3 clinical trial next year.
The company also hopes to receive fast-track designation for its iPPS through engaging with US-based regulatory consultants.
“Today’s ground-breaking data also greatly strengthens the iPPS/osteoarthritis licensing package and provides a significant boost to partnering prospects,” Mr Kaufman noted.
According to Paradigm, osteoarthritis is the world’s most common joint disease and affects more than 30 million adults in the US – costing the economy around US$128 billion a year.
In Australia, about 3 million people are believed to suffer from the disease.
By using iPPS to treat the disease, Paradigm hopes to offer an effective alternate treatment to opioids with more than 115 people die from overdosing each day in the US.
The US Centre for Disease Control and Prevention estimates opioid misuse costs the US $78.5 billion each year.
Paradigm is also targeting using iPPS to treat bone marrow edema lesions, Mucopolysaccharide (MPS), Ross River virus and Chikungunya.